GINETTE TABLETS

Product Description

CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG) GINETTE TABLETS

WHAT IS QUALITATIVE AND QUANTITATIVE COMPOSITION FOR CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG)(GINETTE TABLETS)?

Each coated tablet contains 2.0 mg Cyproterone Acetate and 0.035 mg Ethynylestradiol (In memo pack containing 21 coated tablets)

WHAT IS CLINICAL PARTICULARS FOR CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG)(GINETTE TABLETS)?

INDICATION

For the treatment of Androgen-dependent diseases in women, such as acne and mild forms of hirsutism

WHAT IS DOSAGE AND METHOD OF ADMINISTRATION FOR CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG)(GINETTE TABLETS)?

METHOD OF ADMINISTRATION

Oral Use

DOSAGE REGIMEN

HOW TO TAKE GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

Ginette is to be taken regularly in order to achieve therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of Ginette is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administrative rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Ginette can lead to intermenstrual bleeding and could deteriorate the therapeutic and contraceptive reliability.

Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval.

HOW TO START GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding)

WHAT IS CONTRAINDICATION FOR GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

Preparations containing estrogen/progesterone combinations should not be used in the presence of any of the conditions listed below. should any of the condition appear for the first time during their use, the product should be stopped immediately

 • The presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
• Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).
• A high risk of venous or arterial thrombosis
• History of migraine with focal neurological symptoms.
• Diabetes mellitus with vascular involvement.
• severe hepatic disease as long as liver function values have not returned to normal
• Presence or history of liver tumors (benign or malignant).
• Undiagnosed vaginal bleeding.
• Concomitant use with another hormonal contraceptive.
• Known or suspected pregnancy.
• Lactation.
• Hypersensitivity to the active substances or to any of the excipients.

WHAT SHOULD IF I MISSED DOSE FOR GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take the further tablet at the usual time.

If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:

1. tablet-taking must never be discontinued for longer than 7 days.
2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic pituitary ovarian axis.

If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, the possibility of a pregnancy should be considered.

WHAT SHOULD IF I OVERDOSE FOR GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

Seek emergency medical attention, There have been no reports of serious deleterious effects from an overdose. Symptoms that may occur in this case are nausea, vomiting, and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.

WHAT IS COMMON SIDE EFFECTS FOR GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

FROM WHERE I CAN BUY GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?

WHAT IS DISCLAIMER FOR GINETTE (CYPROTERONE (2 MG) + ETHINYLESTRADIOL (0.035 MG))?